Fluorescent Leukocytes as a Marker of Early Sepsis/Severity
Starting soon
Conditions studied: Sepsis, Disseminated Intravascular Coagulation (DIC), Septic Shock
In brief
Sepsis is a medical emergency whose prognosis depends on the early identification of patients at risk of septic shock, but the tools available in the Emergency Department remain insufficient. Neutrophils, key players in immunothrombosis, show alterations detectable via cell fluorescence (e.g., NE-SFL), which are strongly correlated with the severity of sepsis and septic DIC. The FLAMES study will evaluate, from the time of admission to the Emergency Department, the relevance of neutrophil fluorescence as an early biomarker of severity, either alone or integrated into an AI model based on the multiparametric data from the SthemA 801, with comparison to the Sysmex XN. It aims to address an unmet clinical need: the immediate stratification of the risk of severe forms of sepsis. Hypothesis: higher initial fluorescence will identify patients at risk of organ failure, septic shock, or DIC.
Key facts
- Study ID
- NCT07585942
- Run by
- University Hospital, Strasbourg, France
- People needed
- 492
- Starts
- 2026-05-12
- Expected to finish
- 2027-12-12
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Admission to the ED
- Suspected or proven infection defined by the prescription of antibiotic therapy within 24 hours following admission to the ED
- Collection of an EDTA blood sample as part of routine care
- Patient informed and has not expressed opposition
You may not qualify if…
- Pregnancy or breastfeeding
- Legal protection measure (guardianship, curatorship, judicial protection)
Where it is running
- The University Hospitals of Strasbourg, Intensive Care Medicine Department - New Civil Hospital — Strasbourg, France
Full record on ClinicalTrials.gov
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